Safety Study of an Oral Pro-boneTM, Administered to Post... | NCT01397838

Studies
Safety Study of an Oral Pro-boneTM, Administered to Post Menopausal Osteopenic Women

NCT01397838

Sponsor

OsteoBuild Ltd.

Status

Unknown status

Last Update Posted

Jul 20, 2011Estimated

Enrollment

20Estimated

Phase

Phase 1

Conditions

Osteopenia

Interventions

Pro-Bone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Jan 2012Estimated

First Submitted Date

Jul 18, 2011

First Submission Date that Met QC Criteria

Jul 19, 2011

First Posted Date

Jul 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2011

Last Update Posted Date

Jul 20, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
Pro-Bone	Experimental		Drug: Pro-Bone

Name	Type	Description	Arm Group Labels	Other Names
Pro-Bone	Drug	500 mg Capsules of Pro-Bone twice daily	Pro-Bone

Measure	Description	Time Frame
Adverse events recorded throughout the study		4 weeks
Blood and urinalysis values assessed at pre-dose and according to study design.		4 weeks

Measure	Description	Time Frame
Vital signs		4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

BMD as measured by DEXA at screening, should range between (-1)to (-2.5) SD from normal values.
At least 12 months of spontaneous amenorrhea or at least 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy.
Study participants not taking estrogen alone or estrogen/progestin containing drug products.
Study participants not taking any anti-osteoporosis treatment for at list one year.
The following washout periods should be before baseline assessments are made for subjects previously on estrogen alone or estrogen/progestin containing products:
1. 8 weeks or longer for any prior use of estrogen and/or progestin products.
2. 6 months or longer for prior progestin injectable drug therapy.
3. Women between 45 and 65 years (inclusive) of age.
4. BMI 22-30 (inclusive)
5. Non-smoking (by declaration) for a period of at least 6 months.
6. Subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study.
Subjects who provide written informed consent.

Exclusion Criteria:

Women have documentation of a positive screening mammogram (obtained at screening or within 9 months of study enrolment) or abnormal clinical breast examination prior to enrolment in clinical studies.
Known history of significant medical disorder, which in the investigator's judgment contraindicates administration of the study medications.
Any clinically significant abnormality, upon physical examination or in clinical laboratory test, at screening visit.
Known history of drug or alcohol abuse according to participant declaration at screening visit.
Any acute medical situation (e.g. acute infection) within 48 hours of study start, which is considered of significance by the Principal Investigator.
Subjects who are non-cooperative or unwilling to sign consent form.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases